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Tolerability Safety and Efficacy of Sigh Breaths During NIMV in Motor Neuron Disease

Tolerability Safety and Efficacy of Sigh Breaths During NIMV in Motor Neuron Disease

Recruiting
100 years and younger
All
Phase N/A

Overview

Non-invasive mechanical ventilation (NIMV) is the recommended standard of care as initial therapy for patients with motor neuron disease (MND) with deterioration of the respiratory function.

SIGH_01 study is aimed at investigating the tolerability, safety profile and efficacy of sigh breaths during non-invasive mechanical ventilation in patients with MND in comparison to the standard ventilation support protocol.

Eligibility

Inclusion Criteria:

  • Willing and able to give informed consent
  • MND diagnosis according to El-Escorial criteria
  • Non-invasive ventilation indications in accordance with the international guidelines

Exclusion Criteria:

  • Inability to adhere to study visit schedule or lack of reliable caretaker
  • Presence of dementia
  • History of arrhythmia, heart failure or pneumothorax

Study details
    Myelopathy
    Respiratory Failure
    Respiratory Failure
    Amyotrophic Lateral Sclerosis
    Motor Neuron Disease

NCT04240925

Ospedale San Raffaele

16 February 2024

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